Source: LA Times
Date : 29 December 2003

U.S. Scientists' Deals With
Drug Firms Under Review

Director of the National Institutes of Health
may increase disclosure of consulting payments

By David Willman, Times Staff Writer

WASHINGTON — The director of the National Institutes of Health, moving to shore up confidence in the agency, may seek to expand public disclosure of paid consulting arrangements between drug-development companies and his federal employees.

Citing "concerns" raised about the consulting payments, the director of the agency, Dr. Elias A. Zerhouni, said in a letter to the chairman of the House Energy and Commerce Committee that he was taking corrective actions.

"I have ordered a review of financial disclosure requirements for NIH personnel, and after this review, I will act to increase appropriate financial disclosure," Zerhouni wrote in his letter to the committee chairman, Rep. W.J. "Billy" Tauzin (R-La.).

Zerhouni's letter, dated Tuesday, added: "Our mission is too important to the public health of the nation to have it undermined by any real or perceived conflicts of interest…. I believe that the public's interest is best served by complete transparency, full disclosure, independent review, and proactive management and monitoring of all outside relationships."

Zerhouni wrote that he had initiated a review of all nongovernmental payments made to NIH employees since Jan. 1, 1999. Within the next few weeks, he said, "recommendations for appropriate action" will be completed. A copy of the letter was obtained by The Times.

Zerhouni also said that he was in the process of appointing a "blue ribbon panel to fully review ethical policies and practices at NIH and propose recommendations for improving such policies and practices within 90 days." The panel, he said, "will include independent experts in the field of ethics management."

The NIH director wrote that his "ongoing review of outside activity files shows no evidence that patients were harmed or that decisions were influenced" by consulting fees paid to agency employees by research companies.

His goal, Zerhouni said, is "to erase any doubts in the minds of Congress or the public that we remain worthy of the trust and confidence that you have placed in us."

Zerhouni's comments followed a Dec. 7 Los Angeles Times article documenting hundreds of consulting payments from biomedical companies to NIH employees.

The article also reported that, in 2003, more than 94% of the NIH's top-paid employees were not required to publicly disclose consulting income. The employees who report their outside income confidentially are instructed on a government form not to identify the amounts that they are paid.

The article reported that, based on relaxed ethics rules communicated internally by then-NIH Director Harold E. Varmus in November 1995, directors of the agency's research institutes and centers have accepted consulting fees from companies. The article also reported instances in which written pledges by NIH officials not to participate in matters involving companies paying them were not carried out as intended.

Tauzin and Rep. James C. Greenwood (R-Pa.), who is chairman of the House Oversight and Investigations Subcommittee, wrote to Zerhouni on Dec. 8, requesting a full accounting of the industry payments to NIH employees and related documentation.

Reached on Saturday, Greenwood said that his subcommittee within the next three months would hold one or more hearings on conflict-of-interest policies at the NIH. The agency, which for decades has led the federal government's efforts to combat infectious and other diseases, has an annual budget of $27.9 billion.

Greenwood said the NIH needed to increase public disclosure and put an end to high-ranking officials' consulting deals with biomedical companies.

"We have undisclosed contractual, financial relationships between federal employees and businesses very closely associated with their agency," Greenwood said in an interview. "There may be thousands of these relationships. I think that's cause for serious alarm."

Greenwood said he was troubled by policies that allow NIH employees to consult for pay with companies that are involved directly or indirectly in research with the agency.

"This is not just a matter of a revolving door, where at NIH people go from the federal agency to the private sector," he said. "This is a question of a swivel chair, where they sit at one desk and do both jobs."

In particular, Greenwood said, he questions the prudence of allowing NIH's institute and center directors to serve as paid consultants to drug companies.

"I have grave concern about institute directors having outside sources of income," Greenwood said. "It's like deputy secretaries of Defense working for Lockheed Martin."

He added, "I think that it is a great honor to be the head of a center in the NIH. And at some point if you want to take all of the wisdom that you gained in your career and go cash out in the private sector, go for it. But I'm very uncomfortable with these guys having their feet in both camps."

Zerhouni, who became NIH director in spring 2002 as an appointee of President Bush, did not address in his letter whether he believed institute and center leaders should be allowed to continue as consultants to industry. He wrote that "collaborations between public and private scientists and institutions are essential to translating our discoveries into effective treatments and in attracting and retaining outstanding scientists to government service."

Zerhouni offered to meet with Tauzin at the chairman's "earliest convenience to brief" him about the director's plans for changing ethics rules at the NIH. A spokesman for Tauzin said that because of holiday scheduling, his boss had not yet read Zerhouni's letter.

Greenwood, for his part, said that Zerhouni "inherited these problems and [is] doing his level best to deal with them…. If the NIH is going to be trusted with this huge budget that we've developed for them, then they have to avoid not only conflict of interest, but the appearance of conflict of interest."

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